A randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYC

• Conditions: ANCA-associated vasculitis (Microscopic Polyangiitis, Wegener's granulomatosis); MedDRA version: 9.1Level: HLTClassification code 10047113Term: Vasculitides NEC

• Registration Number: EUCTR2006-001663-33-IT
• Lead Sponsor: Vasculitis and Lupus Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-28
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1)New diagnosis of ANCA-associated vasculitis 2) Active disease (defined by at least one major or three minor BVAS 2003 items, see appendix 1) 3) ANCA positivity (c-ANCA and PR3-ANCA or p-ANCA and MPO-ANCA) or histology confirming active vasculitis from any organ 4) Written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Previous treatment with: (x) MMF: more than two weeks ever; (x) Cyclophosphamide: more than two weeks daily oral or more than 1 pulse of IV CYC(15mg/kg); (x) Rituximab or high dose intravenous immunoglobulin within the last twelve months; 2) Active infection (including hepatitis B, C, HIV and tuberculosis) 3) Known hypersensitivity to MMF, AZA or CYC 4) Cancer or an individual history of cancer (other than resected basal cell skin carcinoma) 5)Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception 6)Any condition judged by the investigator that would cause the study to be detrimental to the patient 7)Any other multi-system autoimmune disease including Churg Strauss angiitis, SLE, anti GBM disease and cry globulinaemia 8) Active serious digestive system disease (e.g. inflammatory bowel disease) 9) Patients with imminently life threatening vasculitis (diffuse alveolar haemorrhage,intestinal perforation or major haemorrhage, cerebral vasculitis and cardiac vasculitis) 10) Patients with rapidly progressive glomerulonephritis and declining renal function.Defined as estimated GFR fall >20% in previous two weeks. 11)GFR<15mls/min at entry or on dialysis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified